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Australian manufacturing licences and overseas GMP certification

A step-by-step guide

19 March 2019

Book pagination

Version history

Version Description of change Author Effective date
V1.0 Guidance on licensing/certification inspections Office of Manufacturing Quality 29/4/2013
V2.0

Change in title

Reduction in scope (no longer applies to medical device manufacturers)

Rephrasing of content

Publication following consultation with industry in January 2017

Manufacturing Quality Branch and the Regulatory Guidance Team July 2017
V2.1

Added instructions for selecting manufacturer name and site details, and the manufacturing activities in the New Licence application form.

Added clarification for application fees and where declining to contribute to cost of an overseas inspection, the impact on obtaining GMP clearance

Minor editorial changes

Manufacturing Quality Branch March 2019

Book pagination